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Assessing The Effectiveness of a Preoperative High Intensity Interval Training Programme In Older Colorectal Cancer Patients (HITCa)

Primary Purpose

Preoperative Care, Colorectal Neoplasms, Aged

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
HIT
Sponsored by
University of Nottingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Preoperative Care

Eligibility Criteria

18 Years - 88 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Confirmed colorectal cancer
  • Offered curative treatment by the Royal Derby Hospital NHS Foundation Trust Colorectal Cancer Multidisciplinary Team
  • Male and female
  • 18-88 years of age

Exclusion Criteria:

  • Uncontrolled hypertension (BP > 160/100),
  • Angina,
  • Heart failure (class III/IV),
  • Cardiac arrthymias,
  • Right to left cardiac shunt,
  • Recent cardiac event,
  • Previous stroke/TIA,
  • Aneurysm (large vessel or intracranial),
  • Severe respiratory disease including pulmonary hypertension,
  • COPD/asthma with an FEV1 less than 1.5 l,
  • Coagulation disorders,
  • Scarring disorders.
  • Current neoadjuvant chemo/radiotherapy
  • Inability to complete the consent process Involvement in invasive research study in previous 3 months.

Sites / Locations

  • University of Nottingham

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HIT exercise training

Arm Description

Outcomes

Primary Outcome Measures

VO2 peak
Mean difference in VO2 peak following a HIT programme

Secondary Outcome Measures

Anaerobic threshold
Mean difference in anaerobic threshold following a HIT programme
Muscle protein synthesis
Assessment of D2O evaluated muscle protein synthesis following HIT programme
Body composition
DXA and USS assessed changes in lean muscle mass and architecture following a HIT programme
Feasibility
Determination of patient compliance and adherence to HIT programme
Quality of life
Quality of life and performance questionnaires to measure subjective outcomes (EQ-5D, IPAQ, DASI, WEMWBS)

Full Information

First Posted
July 10, 2014
Last Updated
July 26, 2017
Sponsor
University of Nottingham
Collaborators
University Hospitals of Derby and Burton NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02188342
Brief Title
Assessing The Effectiveness of a Preoperative High Intensity Interval Training Programme In Older Colorectal Cancer Patients
Acronym
HITCa
Official Title
Effectiveness of Short Term, High Intensity, Interval Exercise Training in Older Colorectal Cancer Patients in Improving Preoperative Fitness
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nottingham
Collaborators
University Hospitals of Derby and Burton NHS Foundation Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary aim of this study is to determine whether an improvement in aerobic fitness, as judged by an increase in VO2peak, can be achieved within 31 days via HIT programme in a group of older, colorectal cancer patients.
Detailed Description
12 high intensity interval training exercise sessions on a static cycle ergometer, over a period of 31 days. Each session lasts 18 minutes. At the beginning and end of the study the following measures will be used to assess change in fitness, body composition and muscle metabolism. DXA scan, USS of thigh, VO2 peak cycling test, short performance battery tests, quality of life questionnaires and muscle biopsy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preoperative Care, Colorectal Neoplasms, Aged, Exercise

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HIT exercise training
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
HIT
Intervention Description
12 HIT exercise sessions in 31 days on a stationary cycle ergometer
Primary Outcome Measure Information:
Title
VO2 peak
Description
Mean difference in VO2 peak following a HIT programme
Time Frame
After 31 days of HIT
Secondary Outcome Measure Information:
Title
Anaerobic threshold
Description
Mean difference in anaerobic threshold following a HIT programme
Time Frame
After 31 days of HIT
Title
Muscle protein synthesis
Description
Assessment of D2O evaluated muscle protein synthesis following HIT programme
Time Frame
After 31 days of HIT
Title
Body composition
Description
DXA and USS assessed changes in lean muscle mass and architecture following a HIT programme
Time Frame
After 31 days of HIT
Title
Feasibility
Description
Determination of patient compliance and adherence to HIT programme
Time Frame
After 31 days of HIT
Title
Quality of life
Description
Quality of life and performance questionnaires to measure subjective outcomes (EQ-5D, IPAQ, DASI, WEMWBS)
Time Frame
After 31 days of HIT

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
88 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Confirmed colorectal cancer Offered curative treatment by the Royal Derby Hospital NHS Foundation Trust Colorectal Cancer Multidisciplinary Team Male and female 18-88 years of age Exclusion Criteria: Uncontrolled hypertension (BP > 160/100), Angina, Heart failure (class III/IV), Cardiac arrthymias, Right to left cardiac shunt, Recent cardiac event, Previous stroke/TIA, Aneurysm (large vessel or intracranial), Severe respiratory disease including pulmonary hypertension, COPD/asthma with an FEV1 less than 1.5 l, Coagulation disorders, Scarring disorders. Current neoadjuvant chemo/radiotherapy Inability to complete the consent process Involvement in invasive research study in previous 3 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Williams, BSc MBChB FRCA PhD
Organizational Affiliation
University of Nottingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nottingham
City
Derby
State/Province
Derbyshire
ZIP/Postal Code
DE22 3DT
Country
United Kingdom

12. IPD Sharing Statement

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Assessing The Effectiveness of a Preoperative High Intensity Interval Training Programme In Older Colorectal Cancer Patients

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